New FDA Requirements on the Manufacture of Investigational Drugs for Phase 1

GMP News No. 672

GMP News
9 February 2006
 

New FDA Requirements on the Manufacture of Investigational Drugs for Phase 1

 
The FDA is making changes to the cGMP Guide for investigational drugs used in Phase 1 studies.

The Food and Drug Administration (FDA) has extended the current Good Manufacturing Practice Guide (cGMP). In the new section (c) of paragraph 210.2, the Agency lays down new requirements on the manufacture of investigational drugs (including biological and biotechnological ones) for Phase 1 of clinical trials:

§ 210.2, section (c):

An investigational drug for use in a Phase 1 study, as defined in Sec. 312.21(a) of this chapter, is subject to the statutory requirements set forth at 21 U.S.C. 351(a)(2)(B). The production of such drug is exempt from compliance with the regulations in part 211 of this chapter. However, this exemption does not apply to an investigational drug for use in a Phase 1 study once the investigational drug has been made available for use by or for the sponsor in a Phase 2 or Phase 3 study, as defined in Sec. 312.21(b) and (c) of this chapter, or the drug has been lawfully marketed. If the investigational drug has been made available in a Phase 2 or 3 study or the drug has been lawfully marketed, the drug for use in the Phase 1 study must comply with part 211 of this chapter.

(http://www.fda.gov/cber/rules/gmpind.htm)

Up till now, manufacturers had to fulfil the requirements defined in 21 CFR Part 210 and 211 in the manufacture of these drugs. With the extension of paragraph 210.2, the FDA exempts the manufacture of investigational Phase 1 drugs from this regulation. However, it points out at the same time that their manufacture is still subject to current requirements if they are intended for use in the far more comprehensive clinical trials of Phase 2 and 3. This restriction generates questions regarding implementation.

Together with the new requirements, the FDA has published the draft for a guidance titled "IND – Approaches to Complying with cGMP during Phase 1"
(http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0286-gdl0001.pdf). The guidance is intended to help manufacturers of investigational new drugs for Phase 1 to implement suitable monitoring mechanisms in production in order to ensure compliance with the legal requirements. Apart from that, the FDA considers publishing further guidelines in which it will clearly define its expectations on the cGMP-compliant manufacture of investigational drugs for Phases 2 and 3.

The new regulation is planned to come into force on 1 June 2006. Changes of the "Direct Final Rule" depend on relevant comments, which can be handed in until 3 April to the FDA.
  

Especially on biotechnology, we are organising the European conference:
GMP-Compliant Development of Biopharmaceuticals
to be held in Copenhagen, Denmark, from 15-17 May 2006

 
Authors:
Wolfgang Heimes and Dr Gerhard Becker
on behalf of ECA
 

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK